CN117615695A - Devices, systems, and methods for positioning an elongated member within a body lumen - Google Patents

Abstract

The present disclosure relates generally to positioning an elongate member at a target site within a body lumen, for example for taking a biopsy from a peripheral airway. Some embodiments are particularly directed to an elongate member having an embedded transducer positioned at a predetermined rotational angle relative to a projected position of an instrument extending out of a distal opening of a first lumen in the elongate member. In many such embodiments, the rotating transducer may be positioned within a second lumen in the elongate member to generate a radial image comprising the marker embedded in the transducer. Thus, the operator can determine the projected position of the instrument before it is extended out of the lumen. In several embodiments, the embedded transducer may comprise a forward imaging transducer, such as an optical fiber.

Description

Devices, systems, and methods for positioning an elongated member within a body lumen

Technical Field

The present disclosure relates generally to the field of medical devices. In particular, the present disclosure relates to devices, systems, and methods that facilitate positioning an elongate member at a target site within a body lumen.

Background

A variety of medical devices are positioned within body cavities for diagnostic or therapeutic purposes. For example, endoscopy is a procedure for observing the interior of the body using an endoscope. Typically, endoscopic procedures utilize an elongated member (e.g., an endoscope) to access, examine, or interact with the interior of a hollow organ or cavity of a body for diagnostic or therapeutic purposes. Endoscopes typically have direct visualization for viewing the interior of the body and/or may be equipped with ultrasound viewing capabilities. Such endoscopes have a profile diameter that allows insertion of the endoscope into a larger body lumen of a certain diameter, such as the Gastrointestinal (GI) tract or the trachea. For example, one type of endoscope, a bronchoscope, may be used to visualize the interior of an airway until a certain generation of airways having a diameter capable of accommodating the bronchoscope diameter is reached for diagnostic and therapeutic purposes. Bronchoscopes are inserted into the airway through the mouth, nose or tracheostomies. This allows the physician to check the patient's airway for abnormalities such as foreign bodies, bleeding, tumors, or inflammation. Sometimes biopsies can be taken from inside the lungs. In some higher generation airways, the diameter of the airways becomes too narrow to accommodate traditional bronchoscopes, which presents challenges to improved devices with means of accurately navigating, positioning and biopsy tissue within these smaller airways or other lumens of minimal diameter.

Disclosure of Invention

This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not necessarily intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

In one aspect, the present disclosure is directed to a medical device having an elongate member and a rotary transducer. The elongate member may have a proximal end, a distal end, a first lumen extending from the proximal end to a first distal opening proximate the distal end, a second lumen extending from the proximal end to the distal end, and an embedded transducer disposed in a wall of the elongate member. The embedded transducer may be positioned at a predetermined rotational angle relative to a projected position of the instrument extending out of the distal opening of the first lumen. The rotating transducer may be disposed in the second lumen and configured to generate a radial image from within the second lumen. The radial image may include indicia of the projected position of the embedded transducer relative to the instrument at a predetermined angle of rotation.

In some embodiments, the embedded transducer comprises at least a portion of an imaging transducer. In some such embodiments, the embedded transducer includes a distal portion of the fiber optic sensor. In various embodiments, the rotary transducer comprises a rotary imaging transducer. In various such embodiments, the rotational imaging transducer may comprise an ultrasound transducer. In several embodiments, the embedded transducer is disposed within a wall of the second lumen of the elongate member. In many embodiments, the second lumen is positioned in the elongate member between the first lumen and the embedded transducer. In some embodiments, the instrument comprises a pre-curved instrument. In some such embodiments, the instrument comprises one or both of a needle and an ablation probe. In various such embodiments, the elongate member is configured to bend in the first direction when the distal end of the pre-bending instrument is positioned a first distance from the distal opening of the first lumen. In many other such embodiments, the elongate member is configured to straighten when the pre-bending instrument is moved from the first distance to the distal opening of the first lumen. In yet several such embodiments, the elongate member is configured to remain straight (or substantially straight) as the pre-bending instrument extends out of the distal opening of the first lumen. In various embodiments, the predetermined angle of rotation ranges from about 45 degrees to about 315 degrees. In many embodiments, the elongate member has an outer diameter of less than 2mm.

In another aspect, the present disclosure is directed to a system including an elongate member, an instrument, and a rotary transducer. The elongate member may have a proximal end, a distal end, a first lumen, a second lumen, and an embedded transducer. The instrument may be disposed in a second lumen. The embedded transducer may be positioned at a predetermined rotational angle relative to a projected position of the instrument extending out of the distal opening of the first lumen. The rotary transducer may be disposed in the second lumen. The rotating transducer may be configured to generate a radial image from within the second lumen. The radial image may include indicia of the projected position of the embedded transducer relative to the instrument at a predetermined angle of rotation.

In some embodiments, the instrument comprises a pre-curved needle. In various embodiments, the instrument includes a pre-curved ablation probe.

In yet another aspect, the present disclosure is directed to a method. The method may include inserting a distal end of the elongate member into a body lumen. The elongate member may have a proximal end, a distal end, a first lumen, a second lumen, and an embedded transducer. The method may include generating a radial image with a rotating transducer disposed in a second lumen of the elongate member. The radial image may include indicia of the projected position of the embedded transducer at a predetermined angle of rotation relative to the instrument extending out of the distal opening of the first lumen of the elongate member.

In several embodiments, the method includes rotating the elongate member to align the target tissue at a predetermined rotational angle relative to the projected position of the instrument. In several embodiments, the method includes extending an instrument out of a distal opening of a first lumen of the elongate member to obtain a biopsy of the target tissue.

Drawings

Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and are not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated is typically represented by a single numeral. It should be appreciated that various figures included in the present disclosure may omit some components, show portions of some components, and/or present some components as transparent in order to facilitate illustration and description of components that may otherwise appear hidden. For purposes of clarity, not every component is labeled in every figure nor is every component of each embodiment shown where illustration is not necessary to allow those of ordinary skill in the art to understand the disclosure. In the figure:

FIG. 1 illustrates an exemplary medical device according to one or more embodiments disclosed herein.

Fig. 2A-2C illustrate various aspects of steering in accordance with one or more embodiments disclosed herein.

Figures 3A-3C illustrate various aspects of imaging in accordance with one or more embodiments disclosed herein.

Detailed Description

The present disclosure relates generally to positioning an elongate member at a target site within a body lumen, for example for taking a biopsy from a peripheral airway. Some embodiments are particularly directed to an elongate member having an embedded transducer positioned at a predetermined rotational angle relative to a projected position of an instrument extending out of a distal opening of a first lumen in the elongate member. In many such embodiments, the rotating transducer may be positioned within a second lumen in the elongate member to generate a radial image comprising the marker embedded in the transducer. Thus, the operator can determine the projected position of the instrument before it is extended out of the lumen. In several embodiments, the embedded transducer may comprise a forward imaging transducer, such as an optical fiber. In various embodiments, the instrument may have a predetermined curvature. In various such embodiments, a predetermined curvature of the instrument may be used to manipulate the elongate member. For example, the deflection angle of the elongate member may be adjusted by varying the distance of the pre-bending instrument relative to the distal end of the elongate member. Further, one or more of these features may be combined into an elongate member having a size small enough to approximate a narrow peripheral body lumen. These and other embodiments are described and claimed.

Positioning an elongate member of a medical device at a target site within a body lumen presents challenges, such as limiting access to the outer dimensions of a stenosed body lumen. For example, an endobronchial ultrasound (EBUS) endoscope is too large (e.g., an endoscope tube outside diameter exceeding 4.2 mm) to access certain peripheral portions of a body lumen (e.g., peripheral airways of certain generations) where suspected cancerous nodules may be present. Electromagnetic (EM) bronchoscopy can be used to locate a target site (e.g., a suspected cancerous nodule around the airway). However, errors, such as metal distortion and errors in preoperative Computed Tomography (CT) that introduce misalignment of the patient during surgery, may complicate the confirmation of proper positioning of the target site. Thus, the operator may rely on other techniques, such as reusable single element (rotating) ultrasound probes, used in conjunction with EM bronchoscopy to confirm proper positioning at the target site. However, these probes are typically non-steerable and fill the entire lumen (e.g., working channel), so the probe must be removed prior to inserting an instrument (e.g., biopsy needle) into the lumen. Furthermore, device exchange may result in tip movement and removal of the ultrasound probe may not allow the position of the elongate member to be determined once the instrument is inserted, resulting in many challenges, such as a low diagnostic rate of a biopsy. Such limitations can reduce the usability and applicability of medical devices used to position the elongate member at the target site, in some cases resulting in inefficient devices with limited performance. With these factors in mind, the devices, systems, and methods of the present disclosure may achieve a variety of beneficial medical results.

The following detailed description should be read with reference to the drawings, which depict illustrative embodiments. The present disclosure is not limited to the particular embodiments described, as such may vary. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless defined otherwise, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Finally, while embodiments of the present disclosure may be described with particular reference to medical devices, systems and procedures for treating the gastrointestinal system, it should be understood that such medical devices and methods may be used to treat the abdominal cavity, digestive system, urinary tract, genital tract, respiratory system, cardiovascular system, circulatory system tissues, and the like. Structures and configurations and deployment methods for stabilizing, maintaining, and/or otherwise facilitating fluid flow paths may have utility beyond the treatments discussed herein.

As used herein, "proximal" refers to the end of the device that is closest to the user (medical professional or clinician, technician, operator or physician, etc., which terms are used interchangeably herein and include, without limitation, an automated control system or otherwise) along the device when the device is introduced into a patient, and "distal" refers to the end of the device or object that is furthest from the user along the device during implantation, positioning or delivery.

As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

As used herein, unless the context clearly indicates otherwise, the conjunction "and" comprises each structure, component, feature, or the like so combined, and the conjunction "or" comprises one or more structures, components, and features, or the like so combined, alone and in any combination and quantity unless the context clearly indicates otherwise.

It is assumed herein that all numerical values are modified by the term "about," whether or not explicitly indicated. In the context of numerical values, the term "about" generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same effect or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in a context other than numerical values) may be considered to have their ordinary and customary definitions, as understood from and consistent with the specification context, unless otherwise specified. The recitation of numerical ranges or values by endpoints includes all numbers subsumed within that range including the endpoints (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5) and fractions thereof.

Note that references in the specification to "an embodiment," "some embodiments," and "other embodiments," etc., indicate that the embodiments described may include one or more particular features, structures, and/or characteristics. However, such recitation does not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Furthermore, when a particular feature, structure, and/or characteristic is described in connection with an embodiment, it is to be understood that such feature, structure, and/or characteristic may be used in connection with other embodiments unless explicitly described to the contrary.

It is to be understood that the disclosure contained herein is only illustrative and explanatory and is not restrictive. As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "exemplary" rather than "ideal". Although reference is made herein to endoscopes and endoscopic systems, reference to endoscopes, endoscopic systems, or endoscopy should not be construed as limiting the possible applications of the disclosed aspects. For example, the disclosed aspects may be used in conjunction with a duodenal, bronchoscope, ureteroscope, colonoscope, catheter, diagnostic or therapeutic tool or device, or other type of medical device or system.

Referring now to the drawings, wherein like reference numerals are used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding thereof. It may be evident, however, that the novel embodiments may be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form in order to facilitate a description thereof. The intention is to cover all modifications, equivalents, and alternatives falling within the scope of the claims.

Fig. 1 illustrates a medical device 100 according to one or more embodiments disclosed herein. The medical device 100 includes an elongate member 102, an instrument 112, and a rotary transducer 114. The elongate member 102 can include a proximal end 108, a distal end 110, a first lumen 104a extending from the proximal end 108 to the distal opening 106a, a second lumen 104b extending from the proximal end 108 to the distal opening 106b, and an embedded transducer 116. In some embodiments, the embedded transducer 116 may comprise a forward imaging transducer embedded in a wall of the elongate member 102. In many embodiments, the rotary transducer 114 may comprise a radial imaging transducer. In some embodiments, fig. 1 may include one or more components that are the same as or similar to one or more other components of the present disclosure. Furthermore, one or more components of fig. 1, or aspects thereof, may be incorporated into other embodiments of the present disclosure, or excluded from the described embodiments, without departing from the scope of the present disclosure. For example, embodiments of the medical device 100 may exclude the instrument 112 without departing from the scope of the present disclosure. Still further, one or more components of other embodiments of the present disclosure, or aspects thereof, may be incorporated into one or more components of fig. 1 without departing from the scope of the present disclosure. The embodiments are not limited thereto.

In various embodiments, the proximal end 108 of the elongate member 102 can include or be coupled to one or more controllers and/or user interfaces. For example, the medical device 100 may include a controller communicatively coupled to the embedded transducer 116 and/or the rotary transducer 114. The controller may provide an interface that allows an operator to control and monitor the rotary transducer 114 and/or the embedded transducer 116. In some embodiments, the controller may provide torque to rotate the rotary transducer 114.

In many embodiments, the embedded transducer 116 is positioned at a predetermined rotational angle relative to the projected position of the instrument 112 extending from the distal opening 106a to the lumen 104a in the elongate member 102. For example, the embedded transducer 116 may extend through the field of view of the rotary transducer 114 at a predetermined angle of rotation relative to the projected position of the instrument 112 extending from the distal opening 106a of the lumen 104 a. Further, the embedded transducer 116, or at least the portion of the field of view extending through the rotary transducer 114, may be constructed of a material that will cause marking in the radial image (e.g., a material that interacts in a characteristic manner with the imaging energy emitted by the rotary transducer 114).

In various embodiments, the lumens 104a, 104b may extend from the proximal end 108 of the elongate member 102 to the distal openings 106a, 106b, respectively. In several embodiments, lumen 104a may terminate before lumen 104 b. In several such embodiments, terminating lumen 104a before lumen 104b may facilitate imaging the projected location of instrument 112 with rotary transducer 114 while rotary transducer 114 remains within lumen 104 b. Thus, the embedded transducer 116 may cause a marker in the radial image that indicates the projected position of the instrument 112. In some embodiments, the distal openings 104a, 104b may be parallel to one another. In another embodiment, the distal openings 104a, 104b may be perpendicular relative to each other.

In several embodiments, the embedded transducer 116 may be disposed in a wall of the elongate member 102. For example, the embedded transducer 116 may be disposed in a wall of the second lumen 104 b. In another example, embedded transducer 116 may be disposed in a wall of first lumen 104 a. It will be appreciated that the embedded transducer 116 may be disposed in a wall of the elongate member 102 to position the embedded transducer 116 at a predetermined rotational angle relative to the projection of the instrument 112.

As will be described in more detail below, for example, with respect to fig. 3A-3C, in some embodiments, the predetermined rotation angle may be in a range from about 45 degrees to about 315 degrees. For example, the predetermined rotation angle may be about 180 degrees. In several embodiments, the rotary transducer 114 may be positioned within the lumen 104b to generate a radial image of the marker including the embedded transducer 116. Thus, the operator can determine the projected position of the instrument 112 prior to extending the instrument 112 out of the lumen 104 a. As will be described in more detail below, for example, with respect to fig. 2A-2C, in many embodiments, the instrument 112 may additionally or alternatively be used to manipulate the distal end 110 of the elongate member 102.

In one or more embodiments, the embedded transducer 116 can include at least a portion (e.g., a distal portion) of an imaging transducer (e.g., a forward imaging transducer). For example, embedded transducer 116 may refer to or include a waveguide, such as a fiber optic cable, coupled to or included in a fiber optic sensor. In some such examples, at least a portion of the fiber optic sensor may not be embedded in the elongate member, such as by extending beyond the distal end of the elongate member 102. In one embodiment, the embedded transducer 116 may include a distal portion of a fiber optic sensor. In various embodiments, the embedded transducer 116 may include a plurality of waveguides. For example, a first waveguide may be used to collect light from the distal end 110 (e.g., for imaging) and a second waveguide may be used to provide light to the distal end 110 (e.g., for illumination). In other examples, a single waveguide may alternate between collecting light and providing light. In various embodiments, lumen 104b may extend distally farther than lumen 104 a. In various such embodiments, this may facilitate imaging the projected location of the instrument 112 when the rotary transducer 114 is disposed within the lumen 104 a.

In many embodiments, embedded transducer 116 may keep the orientation of embedded transducer 116 fixed and known. Thus, the orientation of the embedded transducer 116 (and thus the radial image) relative to the rotating transducer 114 may be readily determined and used to assist in travel. For example, when the embedded transducer 116 comprises a forward imaging transducer, the radial image produced by the rotating transducer 114 that includes the markings of the embedded transducer 116 may be used for a dome-shaped image around the distal end of the elongated member 100.

In various embodiments, the outer diameter of the elongate member 102 can be less than 2mm, such as 1.5mm or 1.9mm. In one or more embodiments. The outer diameter of the rotary transducer 114 may be less than 1.3mm, for example 1.1mm. In some embodiments, the rotary transducer 114 may comprise a radial intrabronchial ultrasound (rybus) probe. In some such embodiments, the rybus probe may operate between 10 hertz and 70 hertz, for example 40 hertz. In many embodiments, the instrument 112 may include a biopsy needle, for example for transbronchial needle aspiration (TBNA). In many such embodiments, the instrument 112 may comprise a needle between 10 gauge and 40 gauge, such as a 25 gauge needle.

In several embodiments, a transducer generally refers to a device that converts energy from one form to another. In many embodiments, each transducer may be operable to convert one or more electrical signals into one or more physical quantities (e.g., energy, force, torque, light, motion, position, etc.) and/or to convert one or more physical quantities into one or more electrical signals. For example, the transducers (e.g., the rotary transducer 114 and/or the embedded transducer 116) may include one or more of imaging sensors, phased array sensors, position sensors, light emitting diodes, pressure sensors, actuators, inductive sensors, fiber optic sensors, electromagnetic position sensors, and the like.

Fig. 2A-2C illustrate various aspects of manipulating a medical device 200 according to one or more embodiments disclosed herein. Medical device 200 includes an elongate member 202, a pre-bending instrument 204, and a rotary transducer 206. The elongate member 202 has a distal end 214 and includes a lumen 208a having a distal opening 216a and a lumen 208b having a distal opening 216 b. In some embodiments, fig. 2A-2C may include one or more components that are the same as or similar to one or more other components of the present disclosure. For example, the elongate member 202 may be the same as or similar to the elongate member 102. Furthermore, one or more components of fig. 2A-2C, or aspects thereof, may be incorporated into other embodiments of the present disclosure, or excluded from the described embodiments, without departing from the scope of the present disclosure. For example, the pre-bending apparatus 204 may be incorporated into the medical device 100 without departing from the scope of the present disclosure. Still further, one or more components of other embodiments of the present disclosure, or aspects thereof, may be incorporated into one or more components of fig. 2A-2C without departing from the scope of the present disclosure. For example, the embedded transducer 116 may be incorporated into the elongate member 202 without departing from the scope of the present disclosure. The embodiments are not limited in context.

In fig. 2A, the pre-bending instrument 204 is disposed within the lumen 208a first distance from the distal opening 216a, with the elongate member 202 being deflected by an angle 212 relative to the horizontal axis 210. In fig. 2B, the pre-bending instrument 204 is disposed within the lumen 208a second distance from the distal opening 216B and the elongate member 202 is aligned with the horizontal axis 210. In fig. 2C, the pre-bending instrument 204 extends out of the distal opening 216b and the elongate member 202 is aligned with the horizontal axis 210. In other words, the elongate member 202 may be configured to remain straight (or substantially straight) as the pre-bending instrument extends out of the distal opening of the first lumen. In various embodiments described herein, deflection of the elongate member 202 may be used for steering. For example, the angle 212 in combination with the rotation of the elongate member 202 can be used to position the distal end 214 of the elongate member 202 relative to the target tissue. In such examples, imaging with one or more transducers included in the elongate member 202 provides guidance for positioning the distal end 214 of the elongate member 202 relative to the target tissue. In various embodiments, the angle 212 may be adjusted by varying the distance of the pre-bending instrument 204 relative to the distal end of the elongate member 202.

In several embodiments, the angle 212 may be continuously adjusted between a minimum angle and a maximum angle by varying the distance of the pre-bending instrument 204 relative to the distal end 214 of the elongate member 202. In many embodiments, indicia of the distance of the pre-bending instrument 204 relative to the distal end 214 of the elongate member 202 may be provided in a radial image. For example, equally spaced strips along lumen 208a may provide indicia of the distance of pre-bending instrument 204 relative to distal end 214 of elongate member 202 in a radial image. In one or more embodiments, the elongate member 202 can have a predetermined curvature. For example, fig. 2A may illustrate a predetermined curvature of the elongate member 202. It should be appreciated that some embodiments may utilize the pre-bending instrument 204, e.g., for steering, without including embedded transducers and/or rotating transducers.

Fig. 3A-3C illustrate various aspects of imaging with a medical device 300 in accordance with one or more embodiments disclosed herein. The medical device 300 includes an elongate member 302 having a proximal end 314 and a distal end 316, a pre-bending instrument 304, an embedded imaging transducer 306, and a rotational imaging transducer 308. Further, the medical device 300 may utilize the rotational imaging transducer 308 to generate a radial image 318. In some embodiments, fig. 3A-3C may include one or more components that are the same as or similar to one or more other components of the present disclosure. For example, elongate member 302 can be the same as or similar to elongate member 202. Further, one or more components of fig. 3A-3C, or aspects thereof, may be incorporated into other embodiments of the present disclosure, or excluded from the described embodiments, without departing from the scope of the present disclosure. For example, the embedded imaging transducer 306 may be integrated into the elongate member 202 without departing from the scope of the present disclosure. Still further, one or more components of other embodiments of the present disclosure, or aspects thereof, may be incorporated into one or more components of fig. 3A-3C without departing from the scope of the present disclosure. For example, one or more aspects of the directionality discussed with respect to fig. 2A-2C may be incorporated into the medical device 300 without departing from the scope of the present disclosure. The embodiments are not limited thereto.

Fig. 3A includes a side view of a medical device 300 disposed within a body cavity 312. More specifically, fig. 3A may illustrate fields of view of an embedded imaging transducer 306 and a rotational imaging transducer 308 that may be used to position a distal end 316 of an elongate member 302 relative to a target tissue 310. In addition, the illustrated embodiment includes a projected position of the pre-bending instrument 304 as the elongate member 302 is extended. In various embodiments, the medical device 300 may utilize an embedded imaging transducer 306 and a rotating imaging transducer 308 to enable an operator to position the elongate member 302 relative to the target tissue 310, such as to obtain a biopsy or deliver ablation therapy using the pre-bending instrument 304. Thus, in various embodiments, the pre-bending instrument 304 may comprise a biopsy needle or an ablation probe. Furthermore, in several embodiments, the steerability previously discussed may be combined with imaging capabilities to provide a medical device that is capable of traveling to the peripheral airway and obtaining a biopsy or delivering ablation therapy in an efficient and economical manner. In several embodiments, the medical devices described herein may be used to obtain a biopsy of or deliver therapy to a nodule in a peripheral airway of the lung. It should be appreciated that some embodiments may utilize embedded transducers and/or rotating transducers without including the pre-bending apparatus 204, e.g., for steering.

In various embodiments, the medical device 300 may utilize an embedded imaging transducer 306 and a rotating imaging transducer 308 to enable an operator to position the elongate member 302 relative to the target tissue 310, such as to obtain a biopsy using the pre-bending instrument 304. Thus, in various embodiments, the pre-bending instrument 304 may comprise a biopsy needle. Furthermore, in several embodiments, the steerability previously discussed may be combined with imaging capabilities to provide a medical device that is capable of traveling to the peripheral airway and obtaining a biopsy in an efficient and economical manner. In several embodiments, the medical devices described herein may be used to obtain biopsies of nodules in the peripheral airways of the lung. Fig. 3B includes a front view of distal end 316 of elongate member 302. More specifically, FIG. 3B illustrates a predetermined rotational angle 324 between the embedded imaging transducer 306 and the pre-bending instrument 304 relative to the rotational imaging transducer 308. Fig. 3C includes a radial image 318 generated by the rotational imaging transducer 308 in combination with pre-curved instrument markers 320, embedded transducer markers 322, and a predetermined rotation angle 324. In the illustrated embodiment, the predetermined rotation angle 324 is 180 degrees. However, in various embodiments, the predefined rotation angle 324 may be between 0 degrees and 360 degrees. In several embodiments, the predefined rotation angle 324 may be a subset between 0 degrees and 360 degrees, such as between 90 degrees and 270 degrees. In many embodiments, a predetermined angle of rotation that causes the marker to obscure the field of view of the target tissue in the radial image may be avoided. For example, angles between 0 degrees and 45 degrees and angles between 315 degrees and 360 degrees may be avoided. In some embodiments, the predetermined rotation angle 324 may be between 120 degrees and 240 degrees, such as 180 degrees.

In various embodiments, the embedded imaging transducer 306 may extend through the field of view of the rotating embedded imaging transducer at a predetermined rotational angle 324 relative to the projected position of the pre-curved instrument 304 extending out of the elongate member 302. Further, the embedded imaging transducer 306, or at least the portion of the field of view extending through the rotary transducer 114, may be constructed of a material that will cause marking in the radial image (e.g., a material that interacts in a characteristic manner with the imaging energy emitted by the rotary imaging transducer 308). In some embodiments, the fiber optic cable of the embedded imaging transducer 306 may provide embedded transducer markings 322. In one or more embodiments, the embedded transducer marker 322 may include shadows of the embedded imaging transducer 306 in the radial image 318. In several embodiments, a rotational imaging transducer 308 may be positioned within the elongate member 302 to generate a radial image 318 including embedded transducer markers 322. Accordingly, the operator may determine the projected position of the pre-bending instrument 304 prior to extending the pre-bending instrument 304 out of the elongated member 302.

The foregoing discussion has broad application and is presented for purposes of illustration and description, and is not intended to limit the disclosure to the form or forms disclosed herein. It will be appreciated that various additions, modifications and substitutions may be made to the embodiments disclosed herein without departing from the spirit and scope of the present disclosure. In particular, it will be clear to those skilled in the art that the principles of the present disclosure may be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the spirit, essential, scope, or characteristic thereof. For example, various features of the disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of certain aspects, examples, or configurations of the present disclosure may be combined in alternative aspects, embodiments, or configurations. While the present disclosure is presented in terms of embodiments, it should be appreciated that various individual features of the subject matter need not all be present in order to achieve at least some of the desired features and/or benefits of the subject matter or such individual features. Those skilled in the art will appreciate that the present disclosure may be used with many modifications or adaptations of structure, arrangement, proportions, materials, components and otherwise, used in the practice of the present disclosure, which are particularly adapted to specific environments and operative requirements without departing from the principles, spirit or scope of the present disclosure. For example, elements shown as integrally formed may be constructed of multiple parts or elements shown as multiple parts may be integrally formed, the operation of the elements may be reversed or otherwise varied, and the size or dimensions of the elements may be varied. Similarly, although operations or acts or processes are described in a particular order, this should not be understood as requiring such particular order, or all operations, acts or processes to be performed, to achieve desirable results. Further, other embodiments are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims, and not limited to the specific embodiments or arrangements described above or described or illustrated herein. In view of the foregoing, individual features of any embodiment may be used and claimed alone or in combination with features of that embodiment or any other embodiment, the scope of the subject matter is indicated by the following claims and is not limited by the foregoing description.

In the above description and in the following claims, the following will be understood. The phrases "at least one," "one or more," and/or "as used herein are open-ended expressions that are both conjunctive and disjunctive in operation. The terms "a," "an," "some," "first," "second," and the like do not exclude a plurality. For example, the terms "a" or "an" as used herein refer to one or more of the entity. Thus, the terms "a" (or "an"), "one or more" and "at least one" can be used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, leftward, rightward, transverse, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are only used for identification purposes to aid the reader's understanding of the present disclosure, and/or to distinguish areas of relevant elements from each other, and do not limit the position, orientation, or use of the present disclosure. Connection references (e.g., attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. Thus, a join reference does not necessarily infer that two elements are directly connected and in fixed relation to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) do not imply importance or priority, but rather are used to distinguish one feature from another.

The following claims are hereby incorporated into this detailed description by reference, with each claim standing on its own as a separate embodiment of this disclosure. In the claims, the term "comprising" does not exclude the presence of other elements or steps. Furthermore, although individual features may be included in different claims, these may possibly be advantageously combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. Furthermore, singular references do not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.

In accordance with the present disclosure, all of the devices and/or methods disclosed and claimed herein can be made and executed without undue experimentation. Although the apparatus and methods of this disclosure have been described in terms of preferred embodiments, it will be apparent to those of skill in the art that variations may be applied to the apparatus and/or methods and in the steps or in the sequence of steps of the methods disclosed herein without departing from the concept, spirit and scope of the disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the disclosure as defined by the appended claims.

Claims (15)

1. A medical device, comprising:

an elongate member having a proximal end, a distal end, a first lumen extending from the proximal end to a first distal opening proximate the distal end, a second lumen extending from the proximal end to the distal end, and an embedded transducer disposed in a wall of the elongate member, the embedded transducer positioned at a predetermined rotational angle relative to a projected position of an instrument extending out of the distal opening of the first lumen; and

a rotational transducer disposed in the second lumen, the rotational transducer configured to generate a radial image from within the second lumen, the radial image including indicia of a projected position of the embedded transducer relative to the instrument at the predetermined rotational angle.

2. The medical device of claim 1, the embedded transducer comprising at least a portion of an imaging transducer.

3. The medical device of claim 2, the embedded transducer comprising a distal portion of a fiber optic sensor.

4. A medical device according to any one of claims 1 to 3, the rotary transducer comprising a rotary imaging transducer.

5. The medical device of claim 4, the rotational imaging transducer comprising an ultrasound transducer.

6. The medical device of any one of claims 1-5, wherein the embedded transducer is disposed within a wall of the second lumen of the elongate member.

7. The medical device of any one of claims 1-6, wherein the second lumen is positioned between the first lumen and the embedded transducer in the elongate member.

8. The medical device of any one of claims 1-7, wherein the instrument comprises a pre-curved instrument.

9. The medical device of claim 8, wherein the pre-bending instrument comprises a pre-bending needle.

10. The medical device of any one of claims 8-9, wherein the elongate member is configured to bend in a first direction when a distal end of the pre-bending instrument is located a first distance from a distal opening of the first lumen.

11. The medical device of claim 10, wherein the elongate member is configured to straighten as the pre-bending instrument moves from the first distance to the distal opening of the first lumen.

12. The medical device of any one of claims 10-11, wherein the elongate member is configured to be substantially straight when the pre-bending instrument extends out of the distal opening of the first lumen.

13. The medical device of any one of claims 1-12, wherein the predetermined rotation angle ranges from about 45 degrees to about 315 degrees.

14. The medical device of any one of claims 1-13, wherein the instrument comprises an ablation probe.

15. The medical device of any one of claims 1-14, wherein the elongate member has an outer diameter of less than 2mm.